Support program for early postpartum mothers on outpatient medications for opioid use disorder
Adaptation and Implementation of an Evidence-Based Parenting Intervention for Postpartum Women Receiving Medications for Opioid Use Disorder
NA · University of Arkansas · NCT07071766
This program will test whether Proud of Baby and Me helps pregnant women and those up to 12 months postpartum who are on outpatient medications for opioid use disorder stay in treatment and manage parenting and mental health stress.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Arkansas (other) |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT07071766 on ClinicalTrials.gov |
What this trial studies
This interventional pilot implemented at an outpatient MOUD clinic will deliver the Proud of Baby and Me program to people between 28 weeks gestation and 12 months postpartum who are receiving methadone or buprenorphine. The program provides recovery-oriented support targeting common postpartum stressors such as return to opioid use, depression, parenting challenges, neonatal abstinence concerns, and stigma. Outcomes will focus on continued engagement in MOUD and reductions in parenting- and mental-health-related barriers to recovery. The trial is conducted at the University of Arkansas for Medical Sciences in Little Rock.
Who should consider this trial
Good fit: Adults 18 or older who speak English, can give informed consent, are receiving outpatient medications for opioid use disorder, and are between 28 weeks gestation and up to 12 months postpartum.
Not a fit: People who are not yet 28 weeks gestation or more than 12 months postpartum at enrollment, not receiving outpatient MOUD, unable to consent, or who do not speak English are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could help postpartum women on MOUD stay in treatment longer, reduce overdose risk, and improve parenting and mental health outcomes.
How similar studies have performed: Previous work documents high postpartum MOUD discontinuation and some supportive programs have improved retention, but targeted postpartum interventions of this type remain limited and partly untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Understand and speak English * Able to give informed consent * Receiving medications for opioid use disorder in the outpatient clinical setting * Between 28 weeks gestation and up to 12 months postpartum Exclusion Criteria: * Unwilling to consent * Before 28 weeks gestation and beyond 12 months postpartum at enrollment
Where this trial is running
Little Rock, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (RECRUITING)
Study contacts
- Principal investigator: Mollee K Steely Smith, PhD — University of Arkansas
- Study coordinator: Mollee K Steely Smith, PhD
- Email: mksteelysmith@uams.edu
- Phone: 501-526-8174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Substance Use Treatment, Perinatal Substance Use, Parenting